Efficacy Study of Olmesartan Medoxomil on Coronary Atherosclerosis and Epicardial Adipose Tissue(EAT)

Coronary Atherosclerosis Clinical Trial

Official title:

Efficacy Study of Olmesartan Medoxomil on Coronary Atherosclerosis Progression and Epicardial Adipose Tissue(EAT) Volume Reduction in Patients With Coronary Atherosclerosis Detected by Coronary CT Angiography(CCTA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02360956
• Other study ID #: S2014-119-01
• Status: Recruiting
• Phase: Phase 4
• First received: January 15, 2015
• Last updated: February 6, 2015
• Start date: December 2014
• Est. completion date: June 2016

Study information

• Verified date: February 2015
• Source: Chinese PLA General Hospital
• Contact: Zhou Ying
• Phone: 86-15810836908
• Email: zhouying0129[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether olmesartan medoxomil is effective in the treatment of coronary atherosclerosis progression and epicardial adipose tissue(EAT) volume reduction in patients with coronary atherosclerosis detected by coronary CT angiography(CCTA).

Description:

Epicardial adipose tissue(EAT) is directly deposited around the pericardium and coronary artery. By means of paracrine action, it can generate various kinds of cytokines, inflammatory factor and free fatty acids, that can affect the state of coronary endothelial function, inflammation and oxidative stress, which finally aggravate the progression of coronary atherosclerosis. In recent years, clinical studies have shown that EAT is a newly discovered independent risk factor of coronary atherosclerosis.Studies confirm that olmesartan medoxomil can improve endothelial function, resisting thrombosis, improve tissue reconstruction, resisting oxidative stress so as to achieve atherosclerosis resistant. Latest researches show that olmesartan medoxomil can better inhibit rat epididymal adipose cell hypertrophy and inflammatory reaction. Coronary CT angiography(CCTA) has emerged as a noninvasive imaging method for analysis coronary atherosclerosis. The purpose of this study is to determine whether olmesartan medoxomil is effective in the treatment of coronary atherosclerosis progression and EAT volume reduction in patients with coronary atherosclerosis detected by CCTA.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• coronary artery stenosis between 30% and 70% determined by CCTA in essential hypertension patients

• resting diastolic blood pressure (DBP) between 90 and 110 mmHg

• type A and B for coronary artery vascular lesions

Exclusion Criteria:

• secondary hypertension

• coronary artery stenosis less than 30% or greater than 70% determined by CCTA

• contraindications to treatment with olmesartan medoxomil (allergy, glaucoma, digestive ulcer, is currently taking phosphodiesterase-5 inhibitor)

• resting systolic blood pressure (SBP) > 200 mmHg or resting diastolic blood pressure (DBP) > 110 mmHg

• Severe calcification, distortion or type C for coronary artery vascular lesions

• pregnancy

• unwillingness or inability to provide informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Atherosclerosis
• Myocardial Ischemia

Intervention

Drug:
• Olmesartan medoxomil tablets
Dosage must be individualized. The usual recommended starting dose of Benicar is 20mg once daily when used as monotherapy in patients who are not volume-contracted.For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Benicar may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.
• Antihypertensive medication (per doctor suggestion)
Any antihypertensive medication alone or in combination.Calcium channel blockers (CCBs),diuretics, beta-blockers, or other antihypertensive medication except ACE inhibitors or ARBs.The drug dose must be individualed.Dosage must be individualized.The patients should take the antihypertensive drugs according to doctors'suggestion.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Alexopoulos N, McLean DS, Janik M, Arepalli CD, Stillman AE, Raggi P. Epicardial adipose tissue and coronary artery plaque characteristics. Atherosclerosis. 2010 May;210(1):150-4. doi: 10.1016/j.atherosclerosis.2009.11.020. Epub 2009 Nov 20. — View Citation

Cherian S, Lopaschuk GD, Carvalho E. Cellular cross-talk between epicardial adipose tissue and myocardium in relation to the pathogenesis of cardiovascular disease. Am J Physiol Endocrinol Metab. 2012 Oct 15;303(8):E937-49. doi: 10.1152/ajpendo.00061.2012. Epub 2012 Aug 14. Review. — View Citation

Ferrario C. Effect of angiotensin receptor blockade on endothelial function: focus on olmesartan medoxomil. Vasc Health Risk Manag. 2009;5(1):301-14. Epub 2009 Apr 8. Review. — View Citation

Maeda A, Tamura K, Wakui H, Ohsawa M, Azushima K, Uneda K, Kanaoka T, Kobayashi R, Ohki K, Matsuda M, Tsurumi-Ikeya Y, Yamashita A, Tokita Y, Umemura S. Effects of the Angiotensin receptor blocker olmesartan on adipocyte hypertrophy and function in mice with metabolic disorders. Biomed Res Int. 2014;2014:946492. doi: 10.1155/2014/946492. Epub 2014 Jun 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary atherosclerosis progression detected by CCTA	Coronary atherosclerosis progression is defined as =10% diameter reduction or progression of a pre-existing coronary stenosis; or =0.2mm reduction or progression of the minimal luminal area (MLD) in the lesion	12 month	No
Primary	Epicardial Adipose Tissue(EAT) volume detected by CCTA		12 month	No
Secondary	The relationship between coronary atherosclerosis and EAT, as indicated by coronary atherosclerosis progression and epicardial adipose tissue(EAT) volume changes		12 month	No
Secondary	Serum levels of blood lipids	Blood lipids include total cholesterol,triglyceride,high density lipoprotein(HDL) and low density lipoprotein(LDL).	12 month	No
Secondary	Serum levels of blood glucose	Blood glucose is defined as fasting blood glucose(FBG).	12 month	No
Secondary	Circulating surrogate markers of atherosclerosis inflammation including hs-CRP,IL-6,MCP-1,TNF--a and MMP-9	CRP: C reactive protein; IL: Interleukin; MCP: Monocyte chemotactic protein,composite of chemoattractant markers; TNF-a: tumor necrosis factor; MMP: Matrix metalloproteinase.	12 month	No
Secondary	Individual circulating surrogate markers of endothelial function including NO and ET-1	ET: Endothelin	12 month	No
Secondary	Individual circulating surrogate markers of adipose tissue inflammation and metabolism including adiponectin and leptin.		12 month	No